2 NOTICE This document is disseminated under the sponsorship of the U.S. Department of Transportation in the interest of information exchange. The United States Government assumes no liability for the contents thereof. This publication and all Office of Aerospace Medicine technical reports are available in full-text from the Civil Aerospace Medical Institute s publications Web site: 2

3 Technical Report Documentation Page 1. Report No. 2. Government Accession No. 3. Recipient's Catalog No. DOT/FAA/AM-06/9 4. Title and Subtitle 5. Report Date New Refractive Surgery Procedures and Their Implications for Aviation Safety April Performing Organization Code 7. Author(s) 8. Performing Organization Report No. Nakagawa VB, Wood KJ, Montgomery RW 9. Performing Organization Name and Address 10. Work Unit No. (TRAIS) FAA Civil Aerospace Medical Institute P.O. Box Oklahoma City, OK Contract or Grant No. 12. Sponsoring Agency name and Address 13. Type of Report and Period Covered Office of Aerospace Medicine Federal Aviation Administration 800 Independence Ave., S.W. Washington, DC Sponsoring Agency Code 15. Supplemental Notes 16. Abstract Since the early 1980s, civil airmen have been allowed to correct refractive error (i.e., myopia, hyperopia, astigmatism) with corrective surgery. Prior Federal Aviation Administration research studies have shown that the number of civil airmen with refractive surgery continues to increase. A study that reviewed refractive surgery use in civil airmen for the years , reported that the largest percentage had radial keratotomy (RK). A similar study that reported on the years , however, showed that there had been a substantial increase in the percentage of airmen with laser refractive surgery, i.e., photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK). A reference guide on refractive surgery was published in September of 1998 (DOT/FAA/AM-98/25); however, at that time long-term clinical data on PRK and LASIK were not available. The introduction of new refractive surgical techniques (e.g., laser epithelial keratomileusis [LASEK], laser thermal keratoplasty [LTK], conductive keratoplasty [CK], Intacs, phakic IOLs, and presbyopia surgeries) and technology (e.g., wavefront-guided systems, Femtosecond Lasers, inlays, and onlays) has further added to concerns regarding the use of refractive surgical procedures by aviators. In order to provide the aviation community with information to formulate administrative decisions and policies associated with existing and emerging refractive surgical procedures, this paper reviews current procedures and discusses their applicability in the civil aviation environment. 17. Key Words 18. Distribution Statement Aviation Vision, Aeromedical Certification, Refractive Surgery Document is available to the public through the Defense Technical Information Center, Ft. Belvior, VA 22060; and the National Technical Information Service, Springfield, VA Security Classif. (of this report) 20. Security Classif. (of this page) 21. No. of Pages 22. Price Unclassified Unclassified 45 Form DOT F (8-72) Reproduction of completed page authorized i

7 New Refractive Surgery Procedures and Their Implications for Aviation Safety INTRODUCTION Refractive error is a defect of the eye that prevents light rays from being brought to a single focus on the retina. To see clearly, refractive errors are normally corrected with ophthalmic lenses (e.g., glasses, and contact lenses) or refractive surgery. There are three principal types of refractive conditions: myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (light rays from a single point object are not focused at a single point on the retina). Although not a refractive condition, presbyopia (a reduction of accommodative ability occurring with age), which normally occurs about 40 years of age, results in blurred vision at near requiring the use of multifocal or reading glasses. More than 155 million Americans are dependent on spectacles or contact lenses to achieve a quality of vision satisfactory for their daily needs (1). About 16% of these individuals wear contact lenses (2). In the last 25 years, there has been increasing marketing and advertising pressure on those with refractive error advocating a lifestyle free of glasses or contact lenses. The perception of lifestyle improvement is a major factor that influences a patient to seek refractive surgery as an alternative method of refractive correction. In September of 1998, the Office of Aviation Medicine Report The Aeromedical Certification of Photorefractive Keratectomy in Civil Aviation: A Reference Guide (3) was published to provide information to those responsible for making certification decisions regarding two new refractive surgery procedures (Photorefractive Keratectomy [PRK], Laser 1 in situ Keratomileusis [LASIK]) and to assist Aviation Medical Examiners in counseling civil airmen who were interested in having refractive surgery. These procedures have continued to evolve and grow in popularity since that time. In addition, there has been an influx of new refractive surgery procedures. This document reviews long-term effects and visual performance issues of patients with PRK and LASIK that were not available when the original reference guide was published and discusses the benefits and risks associated with the use of new refractive procedures. REFRACTIVE CONDITIONS Myopia A myopic or nearsighted person has difficulty seeing distant objects clearly. Myopia is rare at birth, normally manifesting after the 4 th year of life, with progression relatively constant until the time of puberty, when it may progress more rapidly. The condition occurs when the eyeball grows too long or when the cornea is curved too steeply for the overall length of the eye, causing the refracted image to be focused in front of the retina (Figure 1). Normally, myopia becomes stable at physical maturity. Therefore, between the ages of 20 and 40 years, correction may remain essentially unchanged (4). Even small amounts of myopia result in distant objects being considerably blurred. For example, a Diopter (D) refractive error would result in unaided vision of 20/40 to 20/60 Snellen acuity. While eyeglasses or contact lenses are the primary treatment for myopia, these devices can be a hindrance in some occupations or recreational activities. Lenses for high myopia have thick edges, and the optical image is distorted by minification and optical aberrations. The exact cause of myopia remains unknown. It is believed that heredity and environment play a role in myopic development. When both parents are nearsighted, their children have a greater chance of developing myopia. Environmental factors, such as reading in dim lights or doing excessive amounts of close work, may contribute to myopia. About 30% of the population in North America is myopic (2). Figure 1. Myopia 1 Laser will be the term used in this manuscript for LASER (Light Amplification by Stimulated Emission of Radiation) devices. 1

8 Hyperopia Hyperopia, or farsightedness, is a disorder in which vision is more blurred at near. This occurs when the eye is too short in length or the cornea is too flat, causing an image to be focused behind the retina (Figure 2). At birth, eyes are normally hyperopic (about or D). With aging, the eye normally lengthens. (Note: Each millimeter that the eye is too short is equal to 3.00 D of hyperopic refractive change [4].) Statistics are vague on the prevalence of hyperopia. Some epidemiological studies incorrectly incorporate presbyopia, which also requires plus power lenses, as part of the total percentage of hyperopia in the population. An estimated 40% of Americans are hyperopic (1). Many of these hyperopes are children who are able to overcome their farsightedness due to their ability to accommodate. It is not until most hyperopes are in their late thirties or early forties that they experience clinical symptoms with hyperopia they have had their entire life. Figure 3. Astigmatism Presbyopia Presbyopia (the inability to focus at near) occurs when the crystalline lens loses its ability to accommodate or change in shape (Figure 4). Before developing presbyopia, the crystalline lens becomes flatter or thinner when focusing on objects at distance and becomes rounder or thicker when focusing on objects at near. Virtually everyone experiences some degree of presbyopia by early to mid-forty years of age. The ability to accommodate continues to decrease until about 55 years of age. Presbyopia can occur in combination with any other type of refractive error and can complicate these visual conditions. For example, mildly farsighted individuals may find that they need reading glasses to see at near, while nearsighted people may need bifocals so that they can see comfortably at all distances. Figure 2. Hyperopia Astigmatism Astigmatism causes blurred vision when looking at objects both near and distant. The cornea is normally smooth and uniformly curved on all sides; however, with astigmatism the cornea is irregularly curved (steeper in one meridian) (Appendix A). This irregular shape causes light to bend, or refract, causing light rays to become focused at multiple points, which results in distorted vision at any distance. Astigmatism may occur in addition to myopic or hyperopic conditions (Figure 3). At birth, the cornea is usually spherical; however, by 4 years of age the cornea shape changes. With-the-rule astigmatism occurs as the vertical corneal meridian steepens with age, while against-the-rule astigmatism occurs as the horizontal corneal meridian steepens with age (4). Irregular astigmatism most often occurs if the cornea has been damaged by trauma, inflammation, scar tissue, or developmental anomalies. This type of astigmatism normally cannot be completely corrected by ophthalmic spectacle lenses due to the lack of any geometric form from the irregular corneal surface. Figure 4. Accommodation REFRACTIVE ERROR MODIFICATION TECHNIQUES Eye care physicians have used many different techniques in an attempt to alter or reduce refractive error. Due to the limited success and complications, refractive surgeons no longer use many of these techniques (e.g., cycloplegia, clear lens extraction, and scleral reinforcement) (5). Additionally, there were several refractive procedures that concentrated on modifying the anterior surface of the cornea, which supplies 44 of the 66 D (2/3) of the eye s total refractive power (Appendix A). These refractive surgical procedures (e.g., keratomileusis, keratophakia, epikeratophakia, stromal thermokeratoplasty, and 2

9 intrastromal corneal ring) were more complex and had many complications, which led to their being discontinued (5). This paper will review refractive procedures that are currently being used by refractive surgeons and new procedures that are still in the investigational phase or being performed on a limited basis. Radial Keratotomy Sato of Japan first used radial keratotomy (RK) on a wide scale in In the early 1970s, Dr. Fyodorov of Russia considerably refined this technique. Since the late 1970s when it was first introduced in the United States, RK has been performed on more than a million Americans. The RK procedure involved making radial incisions on the peripheral cornea. These incisions weakened the cornea and allowed intraocular pressure to push the peripheral cornea out and flatten the apex, which reduces myopia (Figure 5). (Note: See Appendix B for surgical criteria table.) In March 1982, a multi-center trial with 10 participating surgeons was designed to determine the outcome of a single, standardized technique for myopia (Prospective Evaluation of Radial Keratotomy or PERK Study), which evaluated 757 eyes with a mandated eight-incision procedure. PERK study data at 5 years reported that two-thirds of patients no longer wore any correction, most of the other one-third only wore a correction part time, 60% were within ± 1.00 D of correction, and 88% had uncorrected visual acuity of 20/40 or better (6). At 5 years, only 13% of eyes reported progressive hyperopic shift of 1.00 D or more, but by 10 years, 43% of eyes had changed in the hyperopic direction by 1.00 D or more (6-9). Of the 374 patients (88%) who returned for the 10-year examination, 70% reported not wearing spectacles or contact lenses for distance vision, 60% were still within ± 1.00 D of correction, and 85% had uncorrected visual acuity of 20/40 or better (7). In addition, other long-term studies reported further complications such as reduced corneal strength (10-13), fluctuation of vision (14-19), glare (20-23), poor refractive predictability (7,24,25), and altitude-induced corneal changes (26-29). With the advent of new laser procedures and many reports on both short- and long-term complications from RK, this procedure is rarely used today. Figure 5. Radial Keratotomy (RK) 3 Photorefractive Keratectomy The excimer laser has been used in ophthalmic and refractive applications since the early 1980s. The laser employs a 193 nanometer (nm) ultraviolet-c light, which is emitted as an excited dimer of the argon fluoride gas mixture. This high-energy laser light causes an almost instantaneous vaporization of small amounts of the cornea by direct photochemical disruption of molecular bonds, with minimal impact on neighboring ocular tissue (30,31). The excimer laser was initially approved by the Food and Drug Administration (FDA) to be used for phototherapeutic keratectomy (32) to reduce corneal scaring. During the photorefractive keratectomy (PRK) procedure, the corneal epithelium is first removed either mechanically or with the excimer laser. After programming the amount of intended refractive change required and baseline eye examination data, a computer-assisted algorithm determines the excimer treatment parameters. The laser is then used to reshape the anterior curvature by removing basement membrane, Bowman s membrane, and portions of the corneal stroma (33) (Figure 6). In October 1995, the FDA approved the use of the excimer laser to perform PRK (34). Initial approval was granted for the correction of low-to-moderate levels of myopia (34). As more information became available, approval was also given to correct higher levels of myopia (35), astigmatism (36), and low-to-moderate levels of hyperopia (37,38) (Appendix B). Figure 6. Photorefractive Keratectomy (PRK) PRK is an outpatient procedure, requires only topical anesthesia, and takes about 10 minutes. The laser beam exposure time is dependent upon the amount of refractive error to be treated (average 30 seconds). After treatment, bandage contact lens(es) are placed on the eye(s) to assist in the healing process and to reduce pain. Treated eye(s) are often painful 1 to 2 hours postoperative and become increasingly painful during the first 8 to 12 hours. By the following day, the pain is reduced considerably, and the cornea is reepithelialized in most patients within 48

10 hours. Vision is usually considerably improved within 3 to 4 days, and most patients become slightly overcorrected for a few weeks before stabilizing. Refractive corrections stabilize within 3 to 6 months for lower amounts of correction but may take 6 to 18 months for higher amounts of correction (39,40). During the evolution of PRK, the ablation zone diameter progressively increased from 3.5 millimeters (mm) to 6.5 mm or more (41). Patients with smaller ablation zones reported a higher incidence of symptomatic halos under night-driving conditions (42,43). The larger optical zone reduced the effect of optical irregularities at the junction of the ablation zone and the untreated cornea, which is thought to cause symptomatic halos (44). (Note: 78% of patients with ablation zones of 5.00 mm reported seeing halos at night (45,46).) Larger ablation zones ( 6 mm) had less critical centering requirements when used for mild-to-moderate refractive corrections (45,47). However, when larger ablation zones are used for higher corrections, centering is critical due to the steep and deep transition zone between the treated and untreated portions of the cornea (48). Precise centration of the laser over the pupil entrance is important, as clear, crisp vision depends upon the regularity and centration of the ablated optical zone. Initially, self-fixation by the patient was used, and there were reports of decentration occurring in about 20% of PRK treatments (49). Patients with decentered ablations have problems with monocular diplopia, glare, and irregular astigmatism (50,51). When this occurs, the most common option for correcting irregular astigmatism is a rigid contact lens. Thus, a patient who had previously been unable to wear contact lenses is at a greater risk for a decrease in best spectacle corrected visual acuity (BSCVA) (40,52). While the epithelium has completely healed within 4 to 5 days after surgery in most cases (53,54), epithelial wound healing has occurred as late as several months after surgery (48). Studies found that a smooth corneal surface at 1 to 3 months after surgery did not guarantee a smooth surface at 6 months, as the extent of deposition of new corneal tissue was unpredictable (55,56). Table 1 presents a synopsis of clinical results for PRK. Those percentages with standard deviation are the average taken from multiple studies. Those with no standard deviation are results from individual reports. A significant amount of data and information are available for lower amounts of myopia (< 6.00 D), while less data are available for higher amounts of myopia (>6.00 D) and for photoastigmatic keratectomy (PARK). (Note: PARK corrects for astigmatism and the combination of astigmatism with myopia or hyperopia.) Additionally, since FDA approval for the use of excimer lasers for the correction of hyperopia and hyperopic astigmatism occurred later, there is less long-term information regarding the efficacy and safety of hyperopic PRK and PARK. However, studies reported a slower recovery of uncorrected visual acuity (UCVA) and BSCVA for hyperopes, as compared with PRK and PARK for myopia (57). PRK patients can develop dry-eye symptoms after surgery. One study, using the patient s non-operated eye as a control, reported postoperative Schirmer test values and break up time (BUT) scores at 6 weeks. The values and scores for the PRK eyes were about half that of the non-operated eye, which resulted in dry-eye problems (110). Another study reported a decrease from mean preoperative Schirmer test values to those at 1 month postoperative after having PRK or PARK. At 6 months, mean values were still lower than preoperative values but had increased somewhat (111). PRK has resulted in the development of corneal haze and regression (reverting to original state of refractive error). Studies have shown association with patient age (no significant difference at > 1 year) (112), biological risks (significantly increases in higher correction with small diameter ablation zone and ocular surface disorders, no gender differences except for females taking oral contraceptives [13.5X more likely to occur]), and environmental factors (increases with exposure to solar radiation, tanning beds). However, no association could be found with contact lens wear, swimming, cigarette smoking, or minor ocular trauma (113). Sharif et al. (114), reported on 9 bilateral patients (18 eyes) who became pregnant during the follow-up period and developed regression and corneal haze. Sixty-six percent of eyes (n=12) regressed and 83% (10/12) of these had regression associated with corneal haze (1+ to 2+ grade). Three patients (6 eyes) that had a stable refraction became pregnant at 5 months postoperative and developed corneal haze and associated myopic regression, which did improve in 50% of eyes after delivery (114). The correlation between eye color and the development of corneal haze has been reported. In a study of 100 blue eyes of white patients and 166 brown eyes of Saudi patients with comparable range of myopia, 95% of the blue eyes were within ± 1.0 D of attempted correction compared, with 89% of the brown eyes at 6-months postoperative. One hundred percent of the blue eyes achieved UCVA of 20/30 or better, compared with 92% of the brown eyes. Five percent of blue eyes developed corneal haze, compared with 29% of the brown eyes. Relative risk for developing haze was found to be 7.72X greater in brown eyes, suggesting that race might be a factor in the development of corneal haze (95). 4

12 There have been reported problems with late-onset corneal haze (LOCH). Diagnostic criterion for LOCH is acute haze of grade 2 occurring between 4 and 12 months postoperative. One study, which followed 314 eyes for 12 to 41 months, reported that 11 eyes developed LOCH after exposure to high levels of environmental UV-radiation (115). The study suggests that the use of UV-protective eyewear should be encouraged during the first year after PRK. In another study that followed 1,000 patients for 12 months, all corneas were clear at 4 months, after 4 months, however, 18 eyes of 17 patients developed LOCH, resulting in decreased visual acuity and regression. Treatment with topical steroids resulted in partial reversal of haze and regression. The study suggests that corneal healing and remodeling may continue for at least 1 year after PRK (116). Compared with reports about RK, initial trials for PRK did not report significant problems with diurnal fluctuation of vision (121), progressive hyperopic shifts (37), reduced corneal strength (122), poor refractive predictability (74), and fluctuation of vision (121). However, long-term PRK studies have reported problems with glare (94,108,119,123), halos (108,124,125), regression (81,126), haze (44,65,98,108,109, ,127,128), decreased visual performance at night (119,129,130), undercorrection (81,131), overcorrection (130,132), loss of BSCVA (40,63,66,68,70,76,94,103,109,133,134), and severe dry eye problems (110,111, ). As a result of these reported problems and advances in laser refractive procedures, PRK has been all but replaced. A survey of refractive surgeons in the United States reported that the percentage performing PRK had decreased from 26% in 1997 to less than 1% in 2002 (138). A list of patientreported satisfaction and complications after PRK surgery is summarized in Table 2. Laser in situ Keratomileusis Laser in situ Keratomileusis (LASIK) is a technique that uses the excimer laser and a specially designed knife blade called a microkeratome, which slices a thin, horizontal flap (100 to 200 µm in depth) off the top of the cornea leaving it connected by a small hinge of tissue (139) (Figure 7). The corneal flap is folded aside, and the excimer laser is used to remove tissue from the corneal stroma (Figure 8). The flap is then replaced. Many patients report seeing clearly immediately after surgery and have little or no discomfort. LASIK was initially used to treat higher amounts of myopia. As surgeons increased their surgical skill, LASIK has become the surgery of choice and is now used to treat even low-to-moderate amounts of myopia, astigmatism, and hyperopia (Figure 9). Initially, refractive surgeons felt that there was no need for clinical trials and FDA approval, since LASIK is a procedure that uses 2 FDA-approved devices. In July 1997, the FDA approved the use of the excimer laser and the microkeratome for the LASIK procedure (140). (Appendix B) Table 2. Patient reported satisfaction and complications after PRK. Myopic PRK Hyperopic PRK Reported Patient Satisfaction Satisfied - very satisfied 70-92% 44, % 90,91 Dissatisfied 3-20% 117,120 Quality of Life Improvement 78% 117 Decrease 17% 117 Correction Required After Surgery None 117, % Sometimes worn 30% 119 Always worn 10% 119 Glare Daytime 55% 62,108, % 90,91 Halos At night 7% 100 Always 34% 62,119 Sometimes 26% 119 Never 40-79% 119 Night Vision Problems Always 32-40% 119 Sometimes 30% 119 Never 30% 119 Decreased night vision 32% 100,118 Increased difficulty driving at night 30-31% % 90,91 6

Overview of Refractive Surgery Michael N. Wiggins, MD Assistant Professor, College of Health Related Professions and College of Medicine, Department of Ophthalmology Jones Eye Institute University of Arkansas

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